1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy

FSHD - Facioscapulohumeral Muscular Dystrophy Clinical Trial

— FSHD  

Official title:

Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159612
• Other study ID #: H-3-2012-163 (fsh)
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: May 13, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

Description:

A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.

The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed with FSHD type 1

Exclusion Criteria:

• Pregnant or breastfeeding women.

• Patients with claustrophobia.

• Patients with implanted metallic parts in the body.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Progression
• FSHD - Facioscapulohumeral Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Other:
• MRI
MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.

Locations

Country	Name	City	State
Denmark	Neuromuscular Research Unit, Department of Neurology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Grete Andersen, MD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat infiltration	Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.	1 year	No
Secondary	Muscle structure	Muscle structure is evaluated with a four-point semi-quantitative visual scale. Two observers evaluate images independently. Changes in evaluation between 1st and 2nd scan are the outcome measure.	1 year	No
Secondary	Muscle strength	Changes in muscle strength between 1st. and 2nd MRI-scan.	1 year	No
Secondary	Back pain	Changes in self-assessed back-pain between 1st. and 2nd scan.	1 year	No
Secondary	Muscle function	Changes in muscle function between 1st and 2nd MRI-scan, measured by a 6 minute walk test, a 14-step-stair test and a 5-times-sit-to-stand-test.	1 year	No

External Links

•   The home-page of neuromuscular research units department in Copenhagen, Denmark